Impact of a Cellular Host-Response Sepsis Diagnostic on Clinical Decision Making in the Emergency Department: A Vignette-Based Study.

Publication/Presentation Date

6-1-2026

Abstract

OBJECTIVES: Sepsis is a complex pathogen-host interaction that traditional laboratories do not easily detect. A test that rapidly assesses immune dysregulation could improve early diagnosis and clinical decision making. This study evaluates ease of application of a new host-response sepsis diagnostic test (IntelliSep; Cytovale, Inc) and its ability to affect decision making, risk stratification, and diagnostic efficacy in the emergency department (ED).

METHODS: This was a case vignette-based, randomized, multisite decision-impact study. We conducted the study with ED clinicians from 3 health care institutions, selected among the 5 participating institutions from a previous observational study. Participants were ED-attending physician/fellows, residents, and advanced practice clinicians. The study excluded interns. Finally, 13 clinicians at site 1, 28 at site 2, and 11 at site 3 (total, n = 52) were included. The study used retrospectively de-identified data from patient cases to generate 100 case vignettes. Each participant reviewed 10 cases with IntelliSep results and 10 cases without.

RESULTS: The study assessed outcomes including impact of the test results on clinical decision making, confidence in decision, and diagnostic accuracy. The test supported or changed/augmented clinician decisions in 86% of cases. The presence of the test significantly increased the proportion of raters with high confidence in their ratings (from 53.1% without, to 63.1% with). Additionally, diagnostic accuracy increased, with a notable increase in sensitivity for critical bands, from 73.1% without the test to 82.8% with it (95% CI, 63.5-81.3 vs 74.6-89.1); this increase was not statistically significant (

CONCLUSION: This paper-based study demonstrates that the IntelliSep host-response sepsis test results could impact clinician decisions and may improve the quality of clinical decision making.

Volume

7

Issue

3

First Page

100358

Last Page

100358

ISSN

2688-1152

Disciplines

Medicine and Health Sciences

PubMedID

41952794

Department(s)

Department of Emergency Medicine

Document Type

Article

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